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 Situation
Solution
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SituationThe life sciences industry is challenged with increasingly stringent regulations, requiring enormous volumes of documentation. Electronic document management has helped to streamline these documentation processes. However, in the life sciences industry, the way in which this documentation is managed comes with its own specific regulations, known as 21 CFR Part 11. These FDA regulations establish criteria under which electronic records and signatures can be considered equivalent to paper-based records and handwritten signatures. Without a Part 11-compliant document management environment, life sciences companies that fail to meet compliance regulations are subject to substantial fines or the shut-down of operations. Technology requirements pertaining to Part 11 compliance include: | • | Security controls to prevent unauthorized access to documents | | • | Time and date-stamped audit trails recording changes to records | | • | Electronic signatures on documents with name, date, and purpose of signature | | • | Policies that hold users accountable for documents |
Although many systems exist that claim to be Part 11-compliant, they are often too complex to be effective. Common complaints include: | • | The inability to collaborate efficiently on documentation while maintaining competitive speed-to-market | | • | Difficulty locating files across multiple databases and applications | | • | Lack of understanding and use of compliant enterprise content management systems | | • | Bottlenecks resulting from having only one "expert" appointed to post documents into a repository |
SolutionThe 2007 Microsoft Office system provides easy-to-use document management tools that can help life science companies of all sizes achieve Part 11 compliance quickly and cost-effectively. Key features that address specific Part 11 requirements include: | • | Document security. Apply restrictions to individual documents and across entire libraries in order to more easily control who can open, copy, print, or forward information. A records vault prevents direct tampering of documents and helps ensure the protection of original versions. Portal access is password-protected, and access to specific content can be restricted based on role. | | • | Detailed auditing. Powerful document tracking functionality provides a detailed, time-stamped audit trail of document management activity. | | • | Digital signatures. The applications of the 2007 Microsoft Office system automatically assess the authenticity of digital signatures and signed documents and alert the administrator if there are any discrepancies. | | • | Automated workflow and policies. Managers can easily configure templates so that all the elements required for compliance (such as specific content fields, digital signature fields, and policy requirements) can be built directly into a Microsoft Office Word 2007 or Microsoft Office Excel 2007 file. This helps support compliant practices and helps ensure that documents are automatically assigned to the right people for review and approval. |
BenefitsBy adopting a 21 CFR Part 11 solution based on the 2007 Microsoft Office system, life sciences companies can: | • | Dramatically simplify the document management processes required for compliance | | • | Reduce errors by using pre-defined templates | | • | Encourage compliant document management practices through familiar, easy-to-use Microsoft technologies | | • | Minimize compliance-related headcount | | • | Reduce compliance and infrastructure costs by leveraging investments in Microsoft products | | • | Implement a solution quickly without disrupting the organization |
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